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The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide combined with Cisplatin | Experimental | Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide combined with cisplatin | Drug | Chidamide combined with cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Defined as numbers of patients achieved complete response and patial response of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment | 6 weeks |
| Progression-free survival (PFS) | Defined as the time from randomization until objective tumor progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ctDNA biomarker | relationship between biomarker and treatment outcome | throughout the treatment period,up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Xue, MD | Department of medical oncology,Fudan University, Shanghai Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kai Xue | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| 6 weeks |
| Scoring of quality of life: EORTC-QLQ-30 | Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome. | 6 weeks |
| D009369 | Neoplasms |